Committee Overview

Committee Overview

The Advanced Therapy Gene Modification Safety Committee (ATGMSC) was convened in 2019 and provides an expert review of clinical trials involving gene therapy or genetically modified micro-organisms (GM, GMO) in addition to the review of trials involving advanced therapy (investigational) medicinal products (AT(I)MPs).

The committee has a broad membership and select members convened depending on the type of product/trial being reviewed.

The remit of the committee is as follows:

For trials involving AT(I)MPs:

  • Trials are reviewed by ACCORD      
  • Committee can provide additional expertise if required
  • Committee review and assess safety, storage, transport, preparation and disposal

For trials involving GM(O):

  • Serves as a committee for NHS Lothian and is registered with Health and Safety Executive (HSE)
  • Review projects for NHS Lothian in addition to review undertaken by ACCORD
  • GMSC review will take into consideration the local infrastructure and capacity to support the research, and assess the risks to the Board, staff and patients.

The primary piece of legislation that applies to the use of genetically modified organisms (GMOs) in the workplace is the Genetically Modified Organisms (Contained Use) Regulations 2014. The GMO Regulations requires anyone intending to use GMOs ensure risks to human health or the environment are minimised through the application of appropriate control measures.

The GMO Regulations require:

  • Risk Assessment for both human and the environment
  • Assignment of containment and control measures and classification of the activity (four classes)
  • Establishment of a gene modification safety committee (GMSC) to review any risk assessment carried out
  • Notification of first use of premises;
  • Notification of certain individual activities (class 2 and above)